Short-term Efficacy of Antidepressant in Patients Underwent TKA
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.
研究概览
简要总结
By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement.
详细描述
In this study, the investigators are going to investigate the efficacy of Duloxetine on pain, physical function, mental health and quality of life in patients underwent TKAs.
The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation.On the basis of the above scheme, the treatment group is going to receiving duloxetine 60mg/24h to 8 weeks after operation.HAMD-17 scale, KSS scale, SF-36 scale and WOMAC scale will be used to evaluate the two groups before and after operation for 4 and 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 51 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria
- •Primary TKA surgery,Varus is smaller than 20°
- •Always there is no history of mental illness, no history of relevant medicine
- •Be able to read and understand Chinese, with good communication skills
- •Voluntary participation in this clinical study
排除标准
- •Previous history of mental and psychological illness
- •With severe diseases in respiratory system, circulatory system or digestive system
- •Allergic to duloxetine and celecoxib
研究组 & 干预措施
KSS scale
Knee Society Score with Duloxetine Hydrochloride
干预措施: Duloxetine Hydrochloride (Drug)
HAMD-17 scale
Hamilton Depression Score with Duloxetine Hydrochloride
干预措施: Duloxetine Hydrochloride (Drug)
SF-36 scale
Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride
干预措施: Duloxetine Hydrochloride (Drug)
WOMAC scale
Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride
干预措施: Duloxetine Hydrochloride (Drug)
结局指标
主要结局
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.
时间窗: up to 6 months
A face-to-face questionnaire will be conducted by two trained interviewers
Function score of participants with Duloxetine as assessed by Knee Society Score after 4 weeks of treatment.
时间窗: up to 6 months
A face-to-face questionnaire will be conducted by two trained interviewers
次要结局
- Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.(up to 6 months)
- Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment.(up to 6 months)
研究者
Zhu Bin
Principal Investigator，Graduate Student
Dalian Municipal Central Hospital